A Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
Completed · Phase 1
Conditions studied: Non-Squamous Non-Small Cell Lung Cancer
In brief
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered with one of three planned regimens: Arm A: paclitaxel and carboplatin in bevacizumab-ineligible NSCLC patients, Arm B: paclitaxel, carboplatin, and bevacizumab in bevacizumab-eligible NSCLC patients and Arm C: pemetrexed, cisplatin, and bevacizumab in bevacizumab-eligible, non-squamous NSCLC patients.
Key facts
- Study ID
- NCT00974584
- Run by
- Genentech, Inc.
- People needed
- 65
- Starts
- 2009-10-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically documented NSCLC with advanced disease (Stage IIIb not eligible for chemoradiotherapy or Stage IV or recurrent disease)
- Adequate organ function as assessed by laboratory tests
- Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
You may not qualify if…
- More than one anti-cancer regimen (chemotherapy or radiotherapy) for advanced NSCLC prior to initiation of study treatment
- Any adjuvant or neoadjuvant anti-cancer therapy within a specified timeframe prior to first study treatment
- History of Grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
- Active autoimmune disease, active infection requiring IV antibiotics, or other current uncontrolled illness
- History of clinically significant cardiac or pulmonary dysfunction
- History of malabsorption syndrome or other condition that would interfere with enteral absorption
- Clinically significant history of liver disease
- Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
- Known brain metastases that are untreated, symptomatic, or require therapy
- Pregnancy, lactation, or breastfeeding
Where it is running
- Study site — Buffalo, New York, United States
- Study site — Villejuif, France
- Study site — Groningen, Netherlands
Full record on ClinicalTrials.gov
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